St. Jude Medical Optisure LDA220 User manual

Optisure™
Defibrillation leads
Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220, LDP230,
LDP220Q, LDP230Q, LDP210Q
User's Manual

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of
its subsidiaries. ST.
JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St.
Jude
Medical, LLC and its related companies.
Pat.
http://patents.sjm.com
©
2017 St. Jude Medical, LLC. All Rights Reserved.

1
Description
Optisure™ Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, LDP230Q, and LDP210Q transvenous tachyarrhythmia leads are steroid-
eluting, active or passive fixation leads, and are designed for long-term attachment to an
implantable cardioverter defibrillator (ICD). All leads have two defibrillation electrodes except for
models LDA210, LDA210Q, and LDP210Q which have one. The leads provide true bipolar rate-
sensing, pacing, and delivery of cardioversion/defibrillation shocks.
Certain Optisure models and lead lengths have been tested for use in the MRI environment and
are designated MR Conditional. See MR Conditional ICD System (page 5).
All models are designed for implantation with the distal tip positioned in the right ventricle. For
models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, and LDA210Q, the tip incorporates an
extendable/retractable helix for fixation in the ventricle. The retractable helix allows the electrical
testing of possible lead positions prior to advancement of the fixation helix. The design of the tip
aids visibility under fluoroscopy. For models LDP220, LDP230, LDP220Q, LDP230Q, and
LDP210Q, the tip of the lead has tines for fixation in the ventricle. The low profile, flat-wire
defibrillation electrodes with silicone rubber backfilling are intended to preclude tissue ingrowth.
Models LDA220, LDA230, LDA220Q, LDA230Q, LDP220, LDP230, LDP220Q, and LDP230Q are
quadripolar leads and models LDA210, LDA210Q, and LDP210Q are tripolar leads.
Portions of the lead body have an Optim™ (silicone polyurethane copolymer) insulation overlay.
The lead body insulation tubing is Optim™ insulation and silicone rubber for long-term
biocompatibility and biostability. The lead body is treated with Fast-Pass™ coating to provide
lubricity during lead implant. Contact Technical Support (page 17) if you have any questions.
After contact with body fluid, the tip electrode elutes an amount less than 1.0 milligram of
dexamethasone sodium phosphate (DSP), a steroid. This minimizes tissue inflammation, which,
in turn, is intended to reduce both acute and chronic pacing thresholds.
For information on the specifications of any lead model, refer to the following tables.
Figure 1. Nominal dimensions of DF4-LLHH lead connector (mm)
1. RV tip
2. RV ring
3. RV coil
4. SVC coil
Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Length (cm) 60, 65, 75 52, 58, 65

2
Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Lead introducer (Fr) 8
Electrode configuration:
Tip electrode helix
Ring electrode cylindrical
Defibrillation
electrode
trifilar coil
Electrode spacing:
Tip to ring
electrode (mm)
11
Tip to distal
defibrillation
electrode (mm)
17
Tip to proximal
defibrillation
electrode (cm)
17 21 n/a 17 21 n/a
Connector type
1
Sense/pace 1 IS-1 bipolar (3.2 mm) connector n/a
Defibrillation 2 DF-1 unipolar
(3.2 mm)
connectors
1 DF-1
unipolar(3.2
mm)
connector
n/a
Sense/pace/
defibrillation
n/a DF4-
LLHH
DF4-
LLHH
DF4-
LLHO
Materials2
Body Fast-Pass™
Conductors
35N LT and 35N LT DFT
Connectors MP35N and stainless steel MP35N
Insulators silicone rubber, Optim™, ETFE, and PTFE
Defibrillation
electrodes
platinum iridium alloy
Pacing electrode
(helix)
titanium nitride-coated platinum iridium alloy
Steroid-eluting
plug
DSP
Electrode surface area (mm
2
):
Pacing tip 6
Pacing ring 17
Distal
defibrillation
367
1St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1 lead
connectors conform to the international connector standard ISO 11318/Amd. 1.
2MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.

3
Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Proximal
defibrillation
638 638 n/a 638 638 n/a
Electrode length:
Pacing tip (mm) 1.80
Pacing ring (mm) 2.79
Distal
defibrillation (cm)
5
Proximal
defibrillation (cm)
8 8 n/a 8 8 n/a
Electrical resistance (Ω):
Pace 60 cm: 17
65 cm: 18
75 cm: 21
52 cm: 15
58 cm: 17
65 cm: 19
Sense 15 < 6
Defibrillation < 6
Maximum diameter
(mm)
2.54 at defibrillation electrodes
Maximum helix
revolutions
20
Table 2. Passive fixation lead technical specifications
LDP220
LDP230
LDP220Q
LDP230Q
LDP210Q
Length (cm) 60,65,75 52,58,65
Lead introducer (Fr) 8
Electrode configuration:
Tip electrode semispherical shape
Ring electrode cylindrical
Defibrillation electrode trifilar coil
Electrode spacing:
Tip to ring electrode
(mm)
11
Tip to distal defibrillation
electrode (mm)
17
Tip to proximal
defibrillation electrode
(cm)
17 21 17 21 n/a
Connector type3
3St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1 lead
connectors conform to the international connector standard ISO 11318/Amd. 1.

4
Table 2. Passive fixation lead technical specifications
LDP220
LDP230
LDP220Q
LDP230Q
LDP210Q
Sense/pace 1 IS-1 bipolar(3.2 mm)
connector
n/a
Defibrillation 2 DF-1 unipolar(3.2 mm)
connectors
n/a
Sense/pace/defibrillation n/a DF4-LLHH DF4-LLHH DF4-LLHO
Materials4
Body Fast-Pass™
Conductors 35N LT and 35N LT DFT
Connectors MP35N and stainless
steel
MP35N
Insulators silicone rubber, Optim™, ETFE, and PTFE
Defibrillation electrodes platinum iridium alloy
Pacing electrode titanium nitride-coated platinum iridium alloy
Steroid-eluting plug dexamethasone sodium phosphate
Electrode surface area (mm
2
):
Pacing tip 3.5
Pacing ring 17
Distal defibrillation 367
Proximal defibrillation 638 638 638 638 n/a
Electrode length:
Pacing tip (mm) 0.45
Pacing ring (mm) 2.41
Distal defibrillation (cm) 5
Proximal defibrillation
(cm)
8 8 8 8 n/a
Electrical resistance (Ω):
Pace 60 cm: 33
65 cm: 36
75 cm: 42
52 cm: 29
58 cm: 32
65 cm: 36
Sense 15 < 6
Defibrillation < 6
Maximum diameter (mm) 2.54 at defibrillation electrodes
Indications
The Optisure™ Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, LDP230Q, and LDP21OQ transvenous leads are indicated for use with
compatible pulse generators (refer to the applicable defibrillator manual for system indications).
They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.
4MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.

5
A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for lead
implantation. If the initial lead configuration is not effective, repositioning of the lead or other lead
configurations should be attempted.
In some patients, a nonthoracotomy lead configuration may not provide reliable conversion of
arrhythmias, and the use of subcutaneous or epicardial patch defibrillation leads should be
considered.
Table 3. Accessories and their intended uses
Accessory
Intended use
Lead cap Insulate and protect the lead connector when it is not
connected to a device.
Stylet Stiffen and support the lead to facilitate placement.
Suture sleeve Protect the lead from damage when it is secured to the
venous entry site.
Vein pick Lift and dilate the vein at the lead entry site.
Stylet guide (funnel, IS-1 models
only)
Assist the insertion of the stylet into the lead connector pin to
facilitate placement.
Clip-on tool Extend and retract the helix of an active-fixation lead.
DF-1 plug (single coil model only) Seal unused lead receptacles.
IS4/DF4 connector sleeve Provide a safe and secure connection and disconnection to
the lead.
Contraindications
Contraindications for use of the Optisure™ leads with an implantable pulse generator include
ventricular tachyarrhythmias resulting from transient or reversible factors such as drug toxicity,
electrolyte imbalance, or acute myocardial infarction. Transvenous lead systems are
contraindicated for patients with tricuspid valvular disease or a mechanical heart valve. Optisure™
leads are contraindicated for patients for whom a single dose of 1.0 mg of dexamethasone sodium
phosphate is contraindicated. Optisure™ leads are contraindicated for use with extra firm (red
color knob) stylets for active fixation lead models.
The lead is not designed, sold, or intended for use other than as indicated.
MR Conditional ICD System
The St. Jude Medical™ MR Conditional lead is part of the St. Jude Medical MR Conditional ICD
system.
An MR Conditional lead is conditionally safe for use in the MRI environment when used in a
complete MR Conditional ICD system and according to the instructions in the MRI Procedure
Information document for the St. Jude Medical™ MR Conditional ICD System.
Patients with an implanted St. Jude Medical MR Conditional ICD system can have an MRI scan if
the conditions for use, as described in the MRI Procedure Information document, are met.
The following models and lead lengths have been tested and determined to be MR Conditional
when used according to the instructions in the MRI Procedure Information document. Models and
lead lengths marked not listed in the table below have not been tested and their use in an MR
environment is not determined.

6
Table 4. MR Conditional models and lead lengths for Optisure leads
Model
Lead Length
MR Status
LDA210Q
58 MR Conditional
LDA210Q
65 MR Conditional
LDA220Q
58 MR Conditional
LDA220Q
65 MR Conditional
Warnings and Precautions
Testing has demonstrated that the St. Jude Medical™ MR Conditional ICD system is
conditionally safe for use in the MRI environment when used according to the instructions in
the MRI Procedure Information document.
Models and lead lengths not listed in the table MR Conditional ICD System (page 5) have not
been tested and its use in an MR environment is not determined.
Package Contents
The lead is packaged separately and supplied sterile. Packages contain:
1 lead with stylet and suture sleeve in place
1 vein pick
2 clip-on tools (active fixation models only)
Stylets of varying firmness
1 stylet guide (funnel, IS-1 models only)
1 DF-1 plug (single coil model only)
Product documentation
IS4/DF4 connector sleeve
Storage
The lead should be stored at room temperature. Permitted storage temperatures are between -5°C
(23°F) and +50°C (122°F).
Potential Adverse Events
Possible complications of the use of transvenous lead systems include, but are not limited to,
supraventricular or ventricular arrhythmias, conduction disturbances, cardiac perforation, cardiac
tamponade, loss of contractility, air embolism, heart wall rupture, myocarditis, post-operative heart
failure, chronic mechanical stimulation of the heart, tricuspid valve dysfunction, lead fracture
necessitating surgical removal, pneumothorax, hemothorax, infection, tissue necrosis, and erosion
of the skin. Specific events and effects are summarized in the following table.
WARNING
Implanted cardiac leads are subjected to a hostile environment within the body
due to constant, complex flexural and torsional forces, interactions with leads

7
and/or the pulse generator, or other forces associated with cardiac contractions
and patient physical activity, posture, and anatomical influences. Cardiac leads’
functional lifetimes can be affected by these and other factors.
Refer to the defibrillator manual for additional system complications and precautions as well as
those specific to the pulse generator.
Table 5. Potential Adverse Events
Event
Possible Effects
Dislodgement, breaching of the lead
insulation, connector fracture, poor
connection to the pulse generator,
electrode fracture, or conductor
discontinuity.
Intermittent or continuous loss of sensing, possibly
resulting in nondetection of arrhythmia; oversensing of
artifact, possibly causing inappropriate delivery of
therapy from the pulse generator; intermittent or
continuous loss of defibrillation, cardioversion, or
pacing therapy; possible muscle or nerve stimulation
in the pocket area; intermittent or continuous loss of
cardioversion/defibrillation therapy, sensing, or pacing
therapies.
Cardiac perforation Intermittent or continuous loss of sensing, cardiac
tamponade, or hemorrhage
Venous perforation Acute hemorrhage (may not be readily apparent), or
cardiac tamponade
Myocardial irritability Premature ventricular contractions, supraventricular
and ventricular tachyarrhythmias
Transvenous implantation procedure Air embolism
Chronic implantation Venous thrombosis and/or obstruction
Contamination Infection requiring removal of lead system, pulse
generator, or both
Post-shock rhythm disturbances Post-shock bradycardia or supraventricular
arrhythmias
Threshold elevation or exit block Loss of efficacy of defibrillation, cardioversion, or
pacing therapy
Shunting or insulating of current during
defibrillation with internal or external
paddles
Increased external defibrillation energy and/or
repositioning of paddles required
Instructions for Use
Required Equipment
Equipment for cardiac monitoring, fluoroscopic imaging, external defibrillation, and measuring
lead signals should be available for immediate use during lead implantation and tachyarrhythmia
induction testing. Additional quantities of all sterile implantable devices should be available in
case of accidental contamination or damage.
Package Inspection
St. Jude Medical packages all leads under clean conditions and sterilizes them using ethylene
oxide gas before shipment. If the lead package and seal are intact, the lead and accompanying

8
components are ready to use. Inspect the package carefully before opening and check the “Use
Before” date on the product label.
Verify that the sterility indicator on the inner package is not purple. Purple indicates that the
package has not been sterilized. Do not use the lead if there appears to be damage to the
package or the lead. If the package is wet, damaged, or punctured, or if the seal is broken,
contact St. Jude Medical.
St. Jude Medical does not recommend use of the product after its expiration date. If the lead
package has been breached outside a sterile field or the expiration date has passed, contact
St. Jude Medical.
Sterilization
The package contents have been sterilized with ethylene oxide before shipment. This lead is
for single use only and is not intended to be resterilized.
If the sterile package has been compromised, contact St. Jude Medical.
Handling the Lead
Use caution when handling the lead. It is designed to be pliable, but it will not tolerate
excessive bending or stretching. Permanent damage to the lead may result from severe
bending, kinking, or stretching, or from excessive manipulation with surgical instruments.
Never apply pressure to the lead with a surgical instrument, such as a hemostat.
Do not try to alter electrodes or apply pressure to the tips of electrodes.
Avoid contact of the electrode with a hard surface and guard against contaminating the lead
tip with insulating materials such as lubricants or medical adhesive.
Use powderless surgical gloves or be sure that talc has been removed from surgical gloves
before handling the lead. Because lead insulation attracts particulate matter such as lint and
dust, minimize contamination by protecting the lead from materials that shed such particles.
Do not immerse the helix electrode in liquid or wipe it with any liquid as this will reduce the
amount of DSP eluted after implantation.
Implantation Procedure
Implantation of a transvenous lead generally involves:
Selecting, isolating, and opening the desired vein.
Inserting the lead using the vein pick and stylets.
Positioning and securing the lead.
Testing the sensing, pacing, and cardioversion/defibrillation functions of the lead.
Suturing the lead in place.
Connecting the lead to the pulse generator
Techniques for implantation vary among physicians and depend on the patient's anatomy and
physical condition. The following description presents a typical technique; other methods may
also be applicable.
CAUTION
If using a percutaneous lead introducer with a hemostasis valve, make sure the
valve allows for appropriate passage of the lead without damaging the lead
body.
To avoid distortion of the Optisure™ lead tip, do not use a St. Jude Medical™
Seal-Away™ hemostasis valve.

9
Stylet Guide (Funnel, IS-1 models only)
Use the stylet guide (funnel) to assist the insertion of a stylet into the lead's IS-1 connector pin.
Insert the stylet guide over the IS-1 connector pin prior to introducing the stylet.
Preparing the Active Fixation Lead
Test the extension and retraction of the helix before implanting the lead.
1. Insert a stylet into the lead, if necessary. Verify that the stylet is fully inserted.
2. Straighten the lead on a flat surface.
3. Pinch the clip-on tool open and insert the connector pin into the first notch. For DF4 leads
only, place the clip-on tool on the larger diameter surface of the connector pin. For all leads,
make sure the clip-on tool remains in this position on the connector pin when you rotate the
clip-on tool to extend the helix and release the handles of the tool so that it grasps the
connector pin firmly.
4. While keeping the lead as straight as possible, grasp the connector boot with one hand and
with the other hand, rotate the clip-on tool clockwise to extend the helix. (Refer to the
Technical Specifications tables for the number of rotations required to extend the helix.) The
helix is fully extended when at least 2 turns are visible beyond the lead tip.
CAUTION
While extending or retracting the helix:
Keep the lead as straight as possible. Bending or kinking the lead body may
interfere with the helix movement or cause damage to the lead.
Do not grasp the lead body. Doing so may interfere with the helix movement or
cause damage to the lead.
5. Rotate the clip-on tool counter-clockwise to retract the helix.
CAUTION
Do not further rotate the connector pin after the helix is fully extended or
retracted. Doing so may damage the helix mechanism.
6. To remove the clip-on tool, pinch the handles and withdraw the connector pin from the tool.
Selecting and Opening a Vein
The suggested entry site is the left cephalic vein entered through a venous cutdown. Alternatively,
the lead may be implanted percutaneously through the left subclavian vein.If a percutaneous
subclavian entry is chosen, the puncture site should be as lateral as possible (in the area under
the lateral two-thirds of the clavicle, lateral to the subclavius muscle). The right subclavian vein
and the internal jugular vein can also be used.
Inserting the Lead
A vein pick included in the package is intended to aid in inserting the lead into the vein. Its use is
optional and depends on the chosen implantation technique.
To use the vein pick, first isolate and open the selected vein with scissors or a scalpel. Orient the
point of the vein pick in the direction the lead will be passed and insert the point through the
incision into the vessel lumen. Raise and tilt the vein pick gently, and pass the lead under the pick
into the vein lumen.
Do not use the vein pick for puncturing the vein, dissecting tissue during cutdown, or
manipulating the lead.

10
Extra stylets are packaged with each lead.
To avoid damage to the lead or to body tissue, do not use excessive force or surgical instruments
to insert a stylet into a lead.
Attempt to keep the lead straight when inserting a stylet; do not insert the stylet into a severely
bent lead. Hold the lead at the connector end with the lead straight while removing the stylet to
avoid stress on the lead body.
Keep the stylet clean and free of blood and tissue contact. Accumulated blood and/or tissue on
the stylet may hinder its passage into or removal from the lead and make future insertion of stylets
impossible.
Positioning the Active Fixation Lead
Confirm that the helix is completely retracted before implantation. When the helix is completely
retracted, the helix tip might extend slightly beyond the lead tip.
Note
If blood clogs the helix, repositioning may require a greater number of pin rotations to
extend the helix. Repeated repositioning attempts may impair the helix extension
mechanism.
1. Under fluoroscopic guidance and with the helix retracted, advance the lead into the right
atrium.
2. To aid in passing the lead through the tricuspid valve and into the right ventricle:
-remove the stylet from the lead
-shape the distal end of the stylet into a gentle curve
-carefully reinsert the stylet into the lead
-To avoid damage to the stylet and lead, do not attempt to curve the stylet while it is
inserted in the lead. Do not use a sharp object to curve the distal end of the stylet.
3. Under close fluoroscopic monitoring, advance the curved lead/stylet through the tricuspid
valve.
4. Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves or
penetrating the heart muscle when it continues down into the ventricle.
5. Continue to advance the lead. When the tip reaches position in the right ventricle, retract the
stylet an additional ten centimeters or more.
Accurate electrode positioning is vital for stable sensing and pacing. Verify that the lead tip is
not placed in the coronary sinus or in a retrograde position, and that the entire distal
defibrillation coil is below the tricuspid valve.
6. If desired, evaluate one or more potential fixation sites using the helix tip prior to extending
the helix.
Refer to the appropriate pulse generator manual for the recommended procedures and
values for measuring the sensed R-wave amplitude.
CAUTION
Do not place the lead near another implanted lead. Such close proximity could
result in the electrodes making contact with each other and cause electrical
interference.
7. Once the desired fixation site has been located, hold the lead body stationary in one hand

11
and attach the clip-on tool to the connector pin.
For instructions on using the clip-on tool, see Preparing the Active Fixation Lead (page 9).
8. While keeping the lead as straight as possible, grasp the connector boot with one hand and
with the other hand, rotate the clip-on tool clockwise to extend the helix. (Refer to the
Technical Specifications sheet for the number of rotations required to extend the helix.)
When viewed under fluoroscopy, the helix is fully extended when at least 2 turns are visible
beyond the lead tip (Figure 2).
Figure 2. Extension and retraction of the helix
1. Helix fully extended
2. Helix fully retracted
3. Marker ring
4. Electrically active helix
CAUTION
Do not rotate the connector pin after the helix is fully extended or retracted. Doing
so may damage the helix mechanism.
9. Under fluoroscopy, verify that the helix is extended, then carefully withdraw the stylet while
observing the lead's position.
CAUTION
The stylet must be withdrawn before defibrillation testing to prevent potential
malfunction of the lead. However, the sensing and pacing functions of the lead
can be evaluated with the stylet still in place.
10. Verify that the helix is fixed by pulling gently on the lead and checking for resistance.
If the lead is properly fixed, resistance will be felt and the lead will remain in place. A poorly
affixed lead will come loose easily and must then be repositioned.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or the
patient breathes deeply or stretches. At the same time for dual-coil leads, ensure that there
is not an excess of slack which may allow the proximal electrode to contact the tricuspid
valve.
11. Verify proper lead placement by measuring the sensed R-wave amplitude and determining
the pacing threshold.
Refer to the appropriate pulse generator manual for recommended procedures and
acceptable values.
Note
For DF4 leads, use a sterile patient cable with a plunger clip (such as Models 4160 or
4161) or the IS4/DF4 Connector Sleeve (Model EX3151). The use of alligator clips

12
directly on the lead is not recommended because they may damage the lead.
Positioning the Passive Fixation Lead
1. Under fluoroscopic guidance, advance the lead into the right atrium.
2. To aid in passing the lead through the tricuspid valve and into the right ventricle:
-remove the stylet from the lead
-shape the distal end of the stylet into a gentle curve
-carefully reinsert the stylet into the lead
The flexibility of the lead's distal defibrillation coil allows the distal end of the lead to conform
to the shape of the stylet.
CAUTION
To avoid damage to the stylet and lead, do not attempt to curve the stylet while it
is inserted in the lead. Do not use a sharp object to curve the distal end of the
stylet.
3. Under close fluoroscopic monitoring, advance the curved lead/stylet through the tricuspid
valve and into the ventricular chamber.
4. Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves or
penetrating the heart muscle when it continues down into the ventricle.
5. Continue to advance the lead. When the tip reaches position in the right ventricle, retract the
stylet an additional ten centimeters or more.
Accurate electrode positioning is vital for stable sensing and pacing. Verify that the lead tip is
not placed in the coronary sinus or in a retrograde position, and that the entire distal
defibrillation coil is below the tricuspid valve.
CAUTION
Do not place the lead near another implanted lead. Such close proximity could
result in the electrodes making contact with each other and cause electrical
interference.
6. Under fluoroscopic guidance, carefully withdraw the stylet while observing the lead's
position.
CAUTION
The stylet must be withdrawn before defibrillation testing to prevent potential
malfunction of the lead. However, the sensing and pacing functions of the lead
can be evaluated with the stylet still in place.
7. Verify that the tined tip is well fixed in a stable position in the trabeculae of the ventricle by
pulling back gently on the lead while observing its position under fluoroscopy.
If the lead is properly fixed, resistance will be felt and the lead will remain in place. A poorly
affixed lead will come loose easily and must then be repositioned.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or the
patient breathes deeply or stretches. At the same time, ensure that there is not an excess of
slack which may allow the proximal electrode to contact the tricuspid valve.
8. Verify proper lead placement by measuring the sensed R-wave amplitude and determining
the pacing threshold.
Refer to the appropriate pulse generator manual for recommended procedures and

13
acceptable values.
Note
For DF4 leads, use a sterile patient cable with a plunger clip (such as Models 4160 or
4161) or the IS4/DF4 Connector Sleeve (Model EX3151). The use of alligator clips
directly on the lead is not recommended because they may damage the lead.
IS4/DF4 Connector Sleeve
The IS4/DF4 connector sleeve is designed for use with an IS4 or a DF4 lead. It provides a safe
and secure connection and disconnection to the lead connector.
1. Insert the IS4 or the DF4 lead into the IS4/DF4 connector sleeve until the lead cannot be
inserted any further.
2. Verify the connector ring electrodes are visible in each of the contact clip windows.
3. Attach all alligator clips to the appropriate connector ring electrodes.
Figure 3. Inserting the lead into the connector sleeve
1. Contact clips
2. Lead connector pin
3. Connector ring electrodes
Figure 4. Connector ring electrodes displayed in the contact clip windows
Figure 5. Attaching the alligator clips
NOTE: Remove alligator clips prior to removing the connector sleeve from the lead.

14
Testing Defibrillation Efficacy
Once acceptable sensing and pacing performance have been verified, defibrillation lead testing
may be performed to determine the voltage/energy requirements for reliable defibrillation, and to
ensure that those requirements are well within the output capabilities of the pulse generator.
If defibrillation is performed, ensure that the stylet has been withdrawn from the implanted lead.
If the tested configuration does not provide effective defibrillation, the lead may be repositioned or
another lead configuration may be chosen and repeat testing may be performed. In some
patients, however, no lead configuration may provide reliable defibrillation, and the use of an
alternative lead system should be considered.
Note
If a thoracotomy is required, it should be done during a separate procedure.
Suturing the Lead
After acceptable lead performance is verified by testing, the position of the lead should be
secured using the suture sleeve to prevent dislodgement or migration. The suture sleeve will
protect the lead insulation and conductor coil against damage from ligatures:
1. Position the suture sleeve to place it near, against, or just inside the vein.
2. Ensure that excess slack in the lead body is removed before suturing by viewing the position
of the lead under fluoroscopy.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or when
the patient breathes deeply or stretches.
3. Using heavy, nonabsorbable suture on the distal groove, secure the suture sleeve to the
vein. Tie the suture firmly but gently to avoid damaging the lead as shown in the figure
below.
4. Use the proximal groove to secure the suture sleeve to the fascia and to the lead by first
creating a base by looping heavy, nonabsorbable suture through the fascia underneath the
groove and tying a knot. Tie sutures firmly around each available groove on the suture
sleeve. The most distal groove may be used to tie off the vein over the suture sleeve.
Figure 6. Suture the lead
1. Vein
2. Fascia
3. Lead body
CAUTION
Damage to the lead insulation, damage to the coil, and impairment of lead
function may result from failure to use suture sleeves, tying the ligatures too

15
tightly, or otherwise creating excessive strain at the insertion site. Never tie a
ligature directly to the lead body. Be careful not to dislodge the lead tip during
suturing. Always use heavy, nonabsorbable suture.
If desired, a second suture sleeve may be utilized for additional security:
1. Carefully open the slit in the sleeve and position the sleeve on the lead body.
2. Follow the procedure (above) to suture and secure the sleeve.
Connecting the Lead to the Pulse Generator
To prevent damage to the lead, avoid the use of excessive force on the lead body or connector. To
avoid dislodgement or potential fracture, do not put the lead under extreme tension or flexion. Do
not apply pressure to the lead with a surgical instrument.
CAUTION
Orient the excess lead length and the pulse generator to minimize the potential for
insulation damage resulting from lead-to-lead or pulse generator-to-lead
interaction. For example, minimize the potential for leads lying on top of each
other under the pulse generator and ensure that there are no sharp bends in the
lead. Lead insulation damage can result in electrical current arcing to the pulse
generator, thereby damaging the high-voltage circuitry, or creating an alternate
electrical current path which may result in compromised therapy delivery. Current
practice indicates that a subcutaneous pocket is preferred over a subpectoral
pocket.5 6
1. Before the lead is connected to the pulse generator, the position of the lead should be
reviewed under fluoroscopy, and the R-wave amplitude and pacing threshold measurements
should be repeated to verify that the lead has not become dislodged or damaged.
Refer to the pulse generator manual for the configuration of the ports on each model.
CAUTION
Grasp the lead as close as possible to the connector while inserting the lead
connector straight into the pulse generator port. If necessary, regrip the lead and
continue to insert the lead connector until it is fully seated in the pulse generator
port.
2. Connect the lead, carefully pushing the lead connector all the way into the pulse generator
ports. Verify visually through the clear top of the pulse generator that the lead connector has
been pushed in completely and can be seen protruding behind the port connector.
Be sure that the setscrew is tightened before implanting the device.
3. To avoid twisting the lead body, loosely roll excess lead length under the pulse generator
before placing the excess lead and the generator in the subcutaneous pocket.
In order to avoid stressing the lead conductors and insulation, the pulse generator should
not be implanted in the subcutaneous pocket with the lead attached to the ports at a sharp
angle.
When placing the pulse generator and the lead into the subcutaneous pocket, do not grip the lead
or the pulse generator with surgical instruments. Use of excessive force or improper instruments
on the lead body or connector during pulse generator placement can cause damage affecting the
long-term reliability of the connector and impairment of its function.
5Furman S, Hayes DL, Holmes DR. A Practice of Cardiac Pacing. 3rd ed. New York: Futura Publishing, Inc.; 1993:286-289.
6Belott, PH, Reynolds, DW. Permanent Pacemaker and Implantable Cardioverter-Defibrillator Implantation. In: Ellenbogen KA, Kay
GN, Wilkoff BL, eds. Clinical Cardiac Pacing and Defibrillation. 2nd ed. Philadelphia, Pa: WB Saunders; 1995:613-615.

16
After connection of the lead to the pulse generator, test the function of the lead with the pulse
generator to ensure sensing, pacing, and cardioversion/defibrillation efficacy.
Post-Implantation Follow-Up
St. Jude Medical strongly recommends pre-discharge and chronic follow-up electrophysiology
studies, including induction of ventricular fibrillation, in order to verify the long-term performance
of the lead system. Follow-up chest x-rays to verify the position of the lead are also recommended.
It is also recommended that repeat testing be performed if the patient’s clinical status or
antiarrhythmic drug therapy has changed.
Removing Chronically Implanted Leads
Cap any abandoned lead and secure the lead cap with sutures to prevent unwanted transmission
of electrical signals from the electrode to the heart. Seal the remaining open end of any severed
lead with medical adhesive and a lead cap. Suture the remnant to adjacent tissue using heavy,
nonabsorbable suture to prevent migration of the lead fragment into the heart.
If the lead or any portion of it is extracted, handle it according to local regulations. Clean the
extracted lead with disinfectant and return it to St. Jude Medical for investigation and safe
disposal. For safety reasons, it is recommended that all used leads be enclosed in a protective
cover.
Please complete an Out of Service/Explant/Patient Death form and return it to St. Jude Medical
with the extracted lead. Whenever possible, send along a printout of the programmed settings of
the pulse generator.
Accessories
Table 6. Accessories available for use with the products described in this manual
Clip-on tool (active fixation models only)
DF-1 plug (single coil model only)
Lead cap
Stylets
Stylet guide (funnel, IS-1 models only)
Suture sleeve
Vein pick
IS4/DF4 connector sleeve
Stylet Color Codes
Table 7. Stylet color codes
Knob Color
Description
Diameter
Light green Extra-soft straight (40 mm taper) 0.014 in/0.36 mm
Green Soft straight (20 mm taper) 0.014 in/0.36 mm
Yellow Firm straight 0.015 in/0.38 mm

17
Technical Support
St. Jude Medical maintains 24-hour phone lines for technical questions and support:
1 818 362 6822
1 800 722 3774 (toll-free within North America)
+ 46 8 474 4147 (Sweden)
+ 61 2 9936 1200 (Australia)
manuals.sjm.com
For additional assistance, call your local St. Jude Medical representative.
Symbols
The following symbols may be found on the product or product label:
Symbol
Description
DF4-LLHH
Quadrapolar connector (low voltage, low voltage, high voltage, high
voltage)
DF4-LLHO
Quadpole connector (low voltage, low voltage, high voltage, open)
Active fixation, Extendable/Retractable
Steroid-eluting
Not to be used when a single dose of 1.0 mg dexamethasone sodium
phosphate is contraindicated
Contains less than 1.0 mg dexamethasone sodium phosphate
Minimum introducer size
Optim lead insulation overlay with Fast-Pass coating
Endocardial
Defibrillation lead
One lead
Authorized EC Representative in the European Community

18
Symbol
Description
Sterilized using ethylene oxide
Accessories
Product literature
Contents
Caution, Consult Accompanying Documents
Consult instructions for use
Follow instructions for use on this website
Date of Manufacture
Reorder number
Country of manufacture; BE- Belgium, MY- Malaysia, US- United States
Do not use if package is damaged
Do not reuse
Manufacturer
Serial number
Temperature limitations
Prescription only
Use by
Device has been demonstrated to pose no known hazards in a specified
MRI environment with specified conditions of use.